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| Name | Class |
|---|---|
| Colgate Palmolive | INDUSTRY |
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A 6-month, parallel-arm, investigator-masked, randomized clinical trial was conducted in patients with MetS and severe periodontitis. Participants were randomly assigned to an Intensive Periodontal Treatment group (IPT; scaling and root planing and azithromycin capsules 500mg/24h/3days) or to a Minimal Periodontal Treatment group (MPT; professional plaque removal and placebo capsules). Blood and subgingival microbiological samples were collected at baseline, 3 and 6 months after therapy. The primary outcome was between-group difference in C-reactive protein (CRP). Secondary outcomes included HbA1c, lipids, α-1 antitrypsin, fibrinogen levels and subgingival microbiota assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimal Periodontal Treatment (MPT) | Sham Comparator | Once the hopeless teeth have been extracted, randomized patients will receive a periodontal prophylaxis, in the form of supragingival removal of all deposits (plaque and calculus) with an ultrasonic scaler in two sessions, 1 week apart. During this week the patients will be prescribed local antiseptics (chlorhexidine rinse, 2x, 10 days) and, after the last session, placebo capsules (one every 24 h for three days). |
|
| Intensive Periodontal Treatment (IPT) | Experimental | Once the hopeless teeth have been extracted, randomized patients will receive non-surgical periodontal therapy in the form of full-mouth scaling and root planing (SRP), in two sessions, 1 week apart, with the use of an ultrasonic scaler (Minipiezon Electromedical Systems EMS, Nyon, Switzerland) and hand instruments, under local anaesthesia. During this week the patients will be prescribed local antiseptics (chlorhexidine rinse, 2x, 10 days) and after the last session, systemic antibiotics (azithromycin 500 mgrs, every 24 h for three days). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scaling and root planning | Procedure | Patients received non-surgical periodontal therapy in the form of full-mouth scaling and root planing (SRP), in two sessions, 1 week apart, with the use of an ultrasonic scaler (Minipiezon Electromedical Systems EMS, Nyon, Switzerland) and hand instruments, under local anaesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in C-reactive protein | Main outcome variable is the change in concentration of C-reactive protein between baseline and 6 months | Baseline, 3 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Probing Pocket Depth | Examination of probing pocket depth will be determined with a periodontal probe and expressed in mm | Baseline, 3 months and 6 months |
| Change in Clinical Attachment Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariano Sanz | University Complutense of Madrid | Principal Investigator |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007333 | Insulin Resistance |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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| Supragingival Prophylaxis | Procedure | Supragingival removal of all deposits (plaque and calculus) with an ultrasonic scaler in two sessions, 1 week apart. |
|
Examination of clinical attachment level will be determined with a periodontal probe and expressed in mm
| Baseline, 3 months and 6 months |
| Change in Plaque Index | Examination of plaque index | Baseline, 3 months and 6 months |
| Change in Bleeding on Probing | Examination of bleeding on probing | Baseline, 3 months and 6 months |
| Change in the presence of selected periodontal pathogens | Selected periodontal pathogens: Aggregatibacter actinomycetemcomitans, Tannerella forsythia, P.gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Campylobacter rectus and Fusobacterium nucleatum | Baseline, 3 months and 6 months |
| Change in the total counts of selected periodontal pathogens | By means of anaerobic culture. Selected periodontal pathogens: Aggregatibacter actinomycetemcomitans, Tannerella forsythia, P.gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Campylobacter rectus and Fusobacterium nucleatum | Baseline, 3 months and 6 months |
| Change in the proportions of selected periodontal pathogens | Selected periodontal pathogens: Aggregatibacter actinomycetemcomitans, Tannerella forsythia, P.gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Campylobacter rectus and Fusobacterium nucleatum | Baseline, 3 months and 6 months |
| Change in the concentration of Inflammatory mediators (IL-1β, IL-6, IL-8 and TNF-α) in plasma and gingival crevicular fluid | The inflammatory mediators will be determined by Luminex | Baseline, 3 months and 6 months |
| Change in the % of Glycated haemoglobin | Analysis of glycated haemoglobin was determined in the Lab of the University Hospital | Baseline, 3 months and 6 months |
| D006946 |
| Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |